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Fen-phen was an anti-obesity medication (an anorectic) which consisted of two drugs: fenfluramine and phentermine. Fenfluramine, and later, a
related drug, dexfenfluramine, was marketed by
American Home Products, now known as Wyeth, but were shown to cause potentially fatal
pulmonary hypertension and heart
valve problems, which eventually led to their withdrawal and legal
damages of over $13 billion.[1]
Phentermine was not shown to cause harmful effects.[1]
Wyeth made drugs marketed as Redux and Pondimin, which were used as
the fenfluramine half of the fen-phen combination formula.[2]

Contents

History

Fenfluramine was first introduced in the 1970s, but was not
popular because it only temporarily reduced weight by a few
pounds.[1]
It sold modestly until the 1990s, when it was combined with
phentermine and heavily marketed.[1]
A similar drug, Aminorex,
had caused severe lung damage and "provided reason to worry that
similar drugs ... could increase the risk of a rare but often fatal
lung disease, pulmonary hypertension."[1]
In 1994, Wyeth official Fred Wilson expressed concerns about
fenfluramine's labeling containing only four cases of pulmonary
hypertension when a total of 41 had been observed, but no action
was taken until 1996.[1]
In 1995, Wyeth introduced Redux (dexfenfluramine, the dextro isomer), which
it hoped would cause fewer adverse effects. However, the FDA's
medical officer, Leo Lutwak, insisted upon a black box
warning of pulmonary hypertension risks. After Lutwak refused
to approve the drug, FDA management had someone else sign it and
approved the drug with no black box warning for marketing in
1996.[1]
European regulators required a major warning of pulmonary
hypertension risks.[1]

In 1996, a case-control study in the New
England Journal of Medicine found a 23-fold increase in
pulmonary hypertension.[3] Later
in 1996, a 30-year-old woman developed heart problems after only a
month of using it; when she died in February 1997, the Boston Herald
devoted a front page article to her.[4] In July
1997, after a technician observed heart abnormalities,[1]
researchers at the Mayo
Clinic released a report on 24 cases of rare valvular disease
in women who took the fen-phen combination.[5]
The FDA alerted medical doctors that it had received nine
additional reports of the same type, and requested all health care
professionals to report any such cases to the agency’s MedWatch
program, or to their respective pharmaceutical manufacturers. The
FDA subsequently received 66 additional reports of heart valve
disease, all primarily associated with fen-phen. There were also
reports of documented heart-valve problems in patients taking only
either fenfluramine or dexfenfluramine. The FDA requested that the
manufacturers of fenfluramine and dexfenfluramine stress the
potential risk to the heart in the drugs' labeling and in patient
package inserts. As of 1997, the FDA was continuing to receive
reports of cardiac valvular disease in persons who had taken these
drugs. This valvular disease typically involves the aortic and mitral valves.

The action was based on findings from doctors who had evaluated
patients taking these two drugs with echocardiograms, a
procedure that can test the functioning of heart valves. The
findings indicated that approximately 30 percent of evaluated
patients had abnormal echocardiograms, even though they had no
symptoms. This percentage of abnormal test results was much higher
than would be expected from a comparatively sized sample of the
population who had not been exposed to either fenfluramine or
dexfenfluramine.

Aftermath

As of 2004, Fen-phen is no longer widely available. In April
2005, American Lawyer magazine ran a cover
story on the Fen-phen mass tort crisis, reporting that more than
50,000 product liability lawsuits had been
filed by alleged fen-phen victims. Estimates of total liability ran
as high as $14 billion. As of February 2005, Wyeth was still in
negotiations with injured parties, offering settlements of $5,000
to $200,000 to some of those who had sued, and stating they might
offer more to those were most seriously injured.[2]
One plaintiff's attorney claimed that "the payments [were] not
going to be large enough to cover medical expenses."[6]
Thousands of injured persons rejected these offers.[2]
At the time, Wyeth announced it has set aside $21.1 billion (U.S.)
to cover the cost of the lawsuits.[2]

In 2008, 60
Minutes ran a broadcast about two Kentucky residents suing
Wyeth because Fen-phen had caused permanent damage to their
hearts.

In August 2009, two Kentucky attorneys were convicted of stealing
fen-phen settlement money from 421 of their former clients. They
were sentenced to 20-25 years in prison and ordered to pay $127.7
million in restitution.[7]